7 important takeaways from the FDA's medical device safety action plan

Rachel Popa -   Print  |

The FDA released a medical device safety action plan to protect patients and promote public health.

 Here are seven key takeaways:

1. The FDA proposed combining the Center for Devices and Radiological Health's premarket and postmarket offices to streamline device regulation.

2. The agency is requiring companies to incorporate security updates and patch capabilities into product designs.

3.The FDA is looking to create a patient safety net through the National Evaluation System for Health Technology to link data from different EHRs, device registries, medical claims and patient-generated data.

4. The plan includes creating a Women’s Health Technologies Strategically Coordinated Registry Network to address gaps in evidence related to women's health.

5. The plan also looks to explore ways to spark innovation in technologies that will enhance device safety.

6. The plan also includes measures that would give the agency the authority to impose new premarket and postmarket safety requirements.

7. The plan is open for public comment until Aug. 17.

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